[Insert Study Number]

SWEDISHMEDICALCENTER

747 Broadway,Seattle, WA 98122-4307

(206) 386-6000

SMC CONSENT FORM FOR THE STORAGE AND USE OF HUMAN BIOLOGICAL MATERIALS FOR FUTURE, UNSPECIFIED RESEARCH

[Insert Study Number]

[Insert Study Title]

Participating Institutions:
Cancer Care Northwest / Olympic Hematology & Oncology Associates
Spokane, Washington / Bremerton, Washington
ColumbiaBasin Hematology & Oncology / Polyclinic
Kennewick, Washington / Seattle, Washington
Evergreen Hematology & Oncology / St. JosephHospital
Spokane, Washington / Bellingham, Washington
FredHutchinsonCancerResearchCenter / SwedishMedicalCenter
Seattle, Washington / Seattle, Washington
Group Health Cooperative / University of WashingtonHospital
Seattle, Washington / Seattle, Washington
HarborviewMedicalCenter / WenatcheeValley Clinic
Seattle, Washington / Wenatchee, Washington
Minor and James Medical Clinics
Seattle, Washington

INVESTIGATOR:______

24-HOUR PHONE:______

You are being asked to contribute some of your specimens and related information for future research. The choice to take part is up to you. No matter what you decide, it will not affect your medical care. It will also not affect your participation in other research studies.

Please read this consent form carefully, and ask questions on anything you do not understand. This is part of the ‘informed consent’ process.

WHAT IS THE PURPOSE OF THIS SPECIMEN REPOSITORY?

Sometimes researchers collect and store many specimens together and use them for different kinds of research, or share the specimens with other scientists; this is called a specimen repository.Research with blood, tissue or body fluids (specimens) can help researchers understand how the human body works. Research can also answer other questions by using specimens. Researchers may develop new tests to find diseases, or new ways to treat diseases. In the future, research may help to develop new products, such as drugs. Specimens are commonly used for genetic research. Research done with your specimens may look for genetic causes and signs of disease.

If you choose to contribute to this repository your specimenswill be used only for research and will not be sold.

The purpose of this particular repository is to… describe purpose for the specimen collection and storage and what you hope to learn from the stored samples.

  • Inform subjects of the purpose of the repository.
  • Inform subjects what specimens are to be collected and/or stored (i.e. blood, tissues, teeth etc).
  • Provide a specific description of the research to be conducted with the specimens if known.
  • Describe the types of genetic research that may be done in the future, e.g, “…looking for relationships between genes, the environment, and people’s habits or diet, and different diseases.” (May omit if there is certainty that genetic research will never occur, but this may be unlikely).

HOW WILL THE SPECIMENS BE COLLECTED?

  • Provide specific details about how the specimen will be collected, OR
  • if specimen already exists from previous clinical sources or research studies, inform subjects.

WHAT WILL HAPPEN TO THE SPECIMENS?

Address specific areas about how the sample will be used and stored:

  • Provide a clear description of the operation of the specimen repository
  • Where will the specimen be stored?
  • Who will have access to the link?
  • When will the specimens be destroyed?
  • Inform subjects of conditions under which data and specimens will be released to other investigators.

WHAT ARE GENOME WIDE ASSOCIATION STUDIES (GWAS)?

Delete if this does not apply to your study and you know data will never be submitted to GWAS

The National Institutes of Health (NIH) has established a national database that will hold information from many individuals across the country, including medical information and genetic information. Your blood and tissues contain genes which are made of DNA that is unique to you. If coded information about you is sent to this national database, access will be controlled and limited to other researchers.

ARE THERE BENEFITS TO CONTRIBUTING TO THIS REPOSITORY?

If you agree to contribute some of your specimens and related information to this repositorythere will be no direct benefit to you[and it may possibly be harmful – if applicable]. The research that may be done with your [identify: tissue, bone marrow, etc. specimens]probably will not help you. Studies that use specimens from this repository may provide additional information that will be helpful in understanding (specify if repository focus known).

Information from studies that use specimens from this repository may be valuable in preventing or treating cancer and other diseases in the future.

WHAT IS INVOLVED IN THE REPOSITORY?

Should you agree to contribute, your [identify: tissue, bone marrow, etc. specimens] will be stored in a repository for future, unspecified research at the following location:

[Identifyspecific contact information as described in the study protocol: SWOG Solid Tumor Tissue Bank, ACOSOG Central Specimen Bank, RTOG Biospecimen Resource, etc.]

[If applicable, include a statement about additional specimen(s) to be newly collected as part of the subject’s agreement to allow leftover specimen(s) to be stored for future, unspecified research. For example, “Also, by agreeing below, samples of your blood will be kept for future unspecified research. You will need to have about two teaspoons of extra blood drawn for this purpose, before starting the study treatment.”]

Your specimens will be given a unique coded number but no information that may directly identify you will be provided. That information is kept entirely separate to protect your privacy. Only a limited number of people from[identify: SWOG, ECOG, RTOG, etc] will be able to link your specimens to your identity.

HOW WILL RESEARCHERS BE ABLE TO ACCESS MY SPECIMENS?

Researchers from universities, hospitals, and other health organizations conduct research using specimensand may contact [identify: SWOG, RTOG, ECOG, etc.] and request samples of your specimens for their studies. [Identify: SWOG, RTOG, ECOG, etc.]will review the way these studies will be done, and decide if any of yourstored specimenscan be used for their studies.

In order to do research with your specimens, researchers may need to know some things about you. For example: Are you male or female? What is your race or ethnic group? How old are you? Have you ever smoked? This helps researchers answer questions about different diseases. This information will be collected by the study staff from your health records as part of your participation in the main treatment study.[Identify: SWOG, RTOG, ECOG, etc.]may give researchers reports about your health, which may include your age, sex, race, disease diagnosis, treatments and family history. These reports, as well as your specimens, will not include any information that may directly identify you. This includesyour name, address, phone number, social security number, etc.

WILL I FIND OUT THE RESULTS OF THE RESEARCH?

You will not receive the results of research done with your specimen. This is because the research can take many years and must use specimens from many different peoplebefore the results are known.

The results of the research will not be given to you, your study doctor, or your regular doctor. Reports about research done with your specimens will not be put in your health records. Results from these tests may be published, but you will not be identified in these publications. The research that may be done with your specimens is not designed specifically to help you. However, it might help people who have cancer and other diseases in the future.

HOW LONG WILL MY INFORMATIONBE IN THE REPOSITORY?

It is not known at this time how long your specimens will be stored and used for future, unspecified research.

WHAT ARE THE RISKS OF CONTRIBUTING TO THE REPOSITORY?

Describe immediate and long-term social, physical, and psychological risks/discomforts related to the specimen collection and storage. Address all risks that are applicable.

The physical risks associated with participation in this effort are [list risks of sample acquisition, if any].

The major risk of your participation is the possible risk of loss of confidentiality of private medical information.

Since DNA can be extracted from [identify: tissue, bone marrow, etc. specimens], potentially harmful information could be gained (for example, paternity). If researchers utilize your DNA, you should realize that every person’s DNA is unique; therefore, it may be possible some day that someone could find out who you are just from knowing your DNA sequence. Information about genetic test results may affect your employment, insurance, or family relationships. We cannot be certain that your genetic results could never be linked to you.

Since we do not yet know the exact questions that will be studied by scientists in the future, we cannot tell you what specific information they will be looking at or what that might mean to you.

HOW AM I PROTECTED?

Indicate how privacy and confidentiality will be protected.

  • Include protection of identifiable data.
  • Describe methods to be used: coding, etc.
  • Describe how the records will be secured.
  • Include who may have access to the records, if names will be used, or if there will be ID numbers only, and a linkage file.

[if applicable] Information from your medical records may be stored along with your specimens(s). You will be asked to sign a separate form (“HIPAA authorization”) to allow researchers to review your medical records.

[if applicable] The specimens may be shared with researchers at this or other institutions (include name of other institutions, if known). Research studies may be done at many places at the same time. Your personal identifying information will not be sent to other researchers.

You will not be identified in any report or publication about research using your specimens. Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if disclosure is ever required, Swedish Health Services will take steps allowable by law to protect the privacy of personal information. In some cases, your information in this research could be reviewed by representatives of the hospital, research sponsors, or government agencies for purposes such as quality control or safety.

[include if genetic research] A Federal law called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. GINA does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. GINA also does not protect you against discrimination based on an already-diagnosed genetic condition or disease.

For studies having a federal Certificate of Confidentiality addressing long term storage:

  • Insert language provided by the federal agency that issued the certificate or ask your IRB for appropriate language.

For studies that involve an interpreter:

  • Describe how you will help ensure that the bilingual interpreter will maintain confidentiality.

[Identify: SWOG, RTOG, ECOG, etc.] is in charge of making sure that information about you is kept private. [Identify: SWOG, RTOG, ECOG, etc.] will take steps to prevent misuse of records. Your name, address, phone number and any other identifying information will be taken off anything associated with your specimen and health information before it is given to the researcher. This would make it difficult for any research results to be linked to you or your family. Also, people outside the research process will not have access to results about any one person which will help to protect your privacy.

WHAT OTHER OPTIONS ARE THERE?

You may choose not to contribute to this repository. If you choose not to contribute it will not alter your care or your relationship to any of your doctors.

WHAT ARE THE COSTS?

There will be no cost to you for the storage and use of the specimensfor research purposes.

WILL I BE PAID FOR CONTRIBUTING?

No payment will be made directly to you for taking part in this repository. There are no plans for you to share in the profits that this work may produce.

IS THERE COMPENSATION FOR INJURY?

[Compensation for injury as it relates to your study must be negotiated between the study’s sponsor and the principal investigator. If there is no study sponsor, the principal investigator must discuss compensation language with a SwedishResearchCenter (SRC) Grants and Contracts Analyst.]

WHO IS PAYING FOR THIS REPOSITORY?

Funding for this repository comes from the National Cancer Institute (NCI).

WHAT ARE MY RIGHTS AS A RESEARCH SUBJECT?

You may choose to withdraw your specimens at any time. Just contact your study doctorin writing and let him/her know that you no longer want researchers to use your [identify: tissue, bone marrow, etc. specimens]. You must designate in the written withdrawal whether you would prefer to have the specimens destroyed or returned to your study doctor.

Please be aware that if tests have already been done, then any data that has been obtained from testing your specimens until that point, or information that has been collected about you before you change your mind, may still be used. Changing your mind about using your specimens for research will not affect your ability to continue in the main treatment study.

[Insert as appropriate:] We will tell you about new information that may affect your health, welfare, or willingness to keep your specimens and related information in this repository.

WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?

For questions about the repository or if you have any concerns regarding this repository, contact the study doctor who is treating you on the main study.

For questions about your rights as a research subject, contact the SMC Institutional Review Office (IRO) Manager. The IRO Manager administers the Institutional Review Board (a group of people who review this research to protect your rights and welfare) and may be contacted at (206) 215-2536.

WHERE CAN I GET MORE INFORMATION?

You may call the NCI’s Cancer Information Service at

1–800–4–CANCER (1–800–422–6237) or TTY: 1–800–332–8615

Visit the NCI's Web sites…

cancerTrials: comprehensive clinical trials information

CancerNet™: accurate cancer information including PDQ

CONSENT

I have been given the information about the use and disclosure of my health information for this research study. My questions have been answered.

I authorize the use and disclosure of my health information to the parties listed in the authorization section of this consent for the purposes described above.

I have read the information in this consent form. All my questions about the study and my participation in it have been answered. I freely consent to be in this research study.

If you agree to be in this study, you will receive a signed and dated copy of this consent form for your records.

SUBJECT’S CONSENT AND AUTHORIZATION

My signature indicates that I have been given a copy of this consent form.

Subject’s Signature : / ______
Subject’s Name (Printed): / ______
Date: / ______

MAKING YOUR CHOICE

Please read each sentence below and think about your choice. Please place an “X” next to your decision and initial below. If you have any questions, please talk to your study doctor or nurse.

No matter what you decide to do, it will not affect your care or your ability to participate in the main treatment study.

My specimens may be kept for use in research to learn about, prevent, treat or cure cancer.
_____ Yes_____ NoInitials ______
My specimens may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease).
_____ Yes_____ NoInitials ______
Someone may contact me in the future to ask me to take part in more research. This will be either your study doctor or someone from their office.
_____ Yes_____ NoInitials ______

CERTIFICATE OF PERSON OBTAINING CONSENT:

I have provided an explanation of the above repository, and have encouraged the subject to ask questions and request additional information regarding the repository and possible alternatives. A copy of this consent form has been given to the subject.

Signature of person obtaining consent: / ______
Name (Printed): / ______
Date: / ______

CERTIFICATE OF INVESTIGATOR:

I certify that this subject has been consented.

Signature of investigator: / ______
Investigator Name (Printed): / ______
Date: / ______
Emergency phone number: / ______
Research site: / ______

cc:Subject and Investigator's File

Revision 2 - Template version: 07/07/2014Page 1 of 8